Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00981578
Recruitment Status : Terminated (Terminated due to low enrollment.)
First Posted : September 22, 2009
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief Summary:
A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.

Condition or disease Intervention/treatment Phase
Bone Metastases Device: ExAblate 2100 Not Applicable

Detailed Description:

Bone is the third most common organ involved by metastatic disease behind lung and liver [6]. In breast cancer, bone is the second most common site of metastatic spread, and 90% of patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize to bone most frequently, which reflects the high incidence of both these tumors, as well as their prolonged clinical courses. Post-cancer survival has increased with improvement in early detection and treatments. As a consequence, the number of patients developing metastatic bone disease during their lifetime has also increased.

Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphonates although the primary goal of the use of these therapies are often to address the disease itself), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases [8]. Currently, an off label use of Cryoablation techniques are being tested as another alternative for bone Mets palliation. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described:

  1. Pain relief
  2. Preservation and restoration of function
  3. Local tumor control
  4. Skeletal stabilization

Treatment with external beam radiation therapy (EBRT) is the standard of care for patients with localized bone pain, and results in the palliation of pain for many of these patients. Twenty to 30% of patients treated with radiation therapy do not experience pain relief [9-13]. Re-treatment rates are generally reported in the range of 10-25%. Many patients with relapsed pain or poor response to initial radiation may be lost to follow up or may not be referred back to oncologists for consideration of re-radiation. In addition to relapse and re-treatment, there is an increased risk of pathologic fracture in the peri-radiation period. The fracture rate reported in radiation studies is generally in the range of 1% to 8%. The hyperemic response weakens the adjacent bone and increases the risk of spontaneous fracture. Furthermore, patients who have recurrent pain at a site previously irradiated may not be eligible for further radiation therapy secondary to limitations in normal tissue tolerance. Hesitation on the part of physicians to use a larger dose may be related to increased long-term toxicity. Larger radiation dose produces a greater risk of complications such as fibrosis of normal soft tissue, which can cause a decrement in the quality of life in cases of life expectancy longer than 6 months. There may also be a greater incidence of acute side effects of nausea and vomiting if the treatment field includes the stomach. The percent of patients experiencing vomiting following EBRT ranges from about 5% to 30%.

A palliative treatment for painful bone metastases that is non-invasive, without long-term toxicity and having minimal complications would be a useful tool for treating physicians and also a beneficial option for patients suffering from painful bone metastases. Results of preliminary studies indicate that ExAblate treatment of painful bone metastases may be a beneficial treatment option [14, 15]. The ExAblate system is a non-invasive thermal ablation device used in the coagulation of various types of soft tissue. The ExAblate system has the potential to achieve the first three of the four previously mentioned goals in the treatment of bone tumors; namely pain relief, preservation and restoration of functional levels and local tumor control [11]. The ExAblate system used in the present study is a technological advance over the ExAblate 2000 fixed transducer system in terms of flexibility of use and reduction of positioning related pain to the patients. The ExAblate system used in this study conforms to the patient's body shape at the location of the bone mets location.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System
Study Start Date : September 2009
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : November 14, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Arm Intervention/treatment
Experimental: ExAblate 2100 Treatment
ExAblate 2100 ablation for the treatment of painful bone metastases.
Device: ExAblate 2100
Conformal Bone System
Other Name: Focused ultrasound ablation, MRgFUS




Primary Outcome Measures :
  1. Number of Adverse Device Effects [ Time Frame: 3 months ]
    Adverse effects outcomes are reported in the adverse events module.


Secondary Outcome Measures :
  1. Change in NRS Pain Scores From Baseline at 3 Months [ Time Frame: Baseline, 3 months ]
    Efficacy was evaluated by change in Numerical Rating Scale (NRS) pain scores at 3 months post treatment The NRS is an 11 point scale (0-10) with 0 as no pain and 10 as the worst pain. Larger numbers in score change from baseline indicate improvement (decrease) in pain. Two points improvement has been reported as a clinically meaningful.

  2. Change Brief Pain Inventory - Pain Interference From Baseline at 3 Months [ Time Frame: Baseline, 3 months ]
    Quality of life was evaluated using average change from baseline at 3 Months using the Pain Interference section of the Brief Pain Inventory (BPI-Pain Interference). Larger change from Baseline numbers indicate improved function. Pain Interference is the mean of seven questions scored on an 11-point scale of 0 (does not interfere) to 10 (completely interferes). A positive change from Baseline (higher values) at the 3 Month visit indicates improvement or a reduction in pain interference



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women age 18 and older
  2. Patients who are able and willing to give consent and able to attend all study visits
  3. Patients who are suffering from symptoms of bone metastases
  4. One to 3 painful lesions.
  5. Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 - L5), Sacral vertebra (S1 - S5)
  6. Patients with persistent distinguishable pain associated with up to 3 tumors of which a maximum of 2 tumors will be treated:

    o If patient has pain from additional sites that are not planned for treatment, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site(s) to be treated.

  7. Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors (i.e: both tumors targeted for treatment must have NRS ≥ 4) irrespective of medication
  8. Targeted tumors (most painful) size up to 8 cm in diameter
  9. Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is deeper than 1cm from the skin.
  10. Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
  11. Able to communicate sensations during the ExAblate MRgFUS treatment
  12. At least 2 weeks since chemotherapy
  13. No radiation therapy to targeted (most painful) tumors in the past two weeks

Exclusion Criteria:

  1. Patients who either

    • Need surgical stabilization of the affected weight bearing bony structure (>7 fracture risk score, see Section 6.9) OR
    • Targeted tumor is at an impending fracture site of the weigh bearing bone (>7 on fracture risk score, see Section 6.9).

    OR

    o Patients with surgical stabilization of tumor site with metallic hardware

  2. More than 3 painful lesions or more than 2 requiring immediate localized treatment
  3. The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS.
  4. Targeted tumor is in the skull
  5. Patients on dialysis
  6. Patients with life expectancy < 6-Months
  7. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
  8. Patients with unstable cardiac status including:

    • Unstable angina pectoris on medication
    • Patients with documented myocardial infarction within six months of protocol entry
    • Congestive heart failure requiring medication (other than diuretic)
    • Patients on anti-arrhythmic drugs
  9. Severe hypertension (diastolic BP > 100 on medication)
  10. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
  11. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
  12. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
  13. KPS Score < 60 (See "Definitions" below)
  14. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
  15. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time.)
  16. Target (most painful) tumor-bone interface is less then 1cm from nerve bundles, bowels or bladder.
  17. Are participating or have participated in another clinical trial for the palliation of their targeted bone metastasis tumors in the last 30 days
  18. Patients receiving chemotherapy or radiation (i.e., to the targeted lesion (s)) within the last two weeks
  19. Patients unable to communicate with the investigator and staff.
  20. Patients with persistent undistinguishable pain (pain source unidentifiable)
  21. Targeted (most painful) tumors size > 8 cm in diameter
  22. Targeted (most painful) tumors:

    • NOT visible by non-contrast MRI, OR
    • NOT accessible to ExAblate device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981578


Locations
Layout table for location information
United States, California
City of Hope
Duarte, California, United States, 91010
University of California San Francisco
San Francisco, California, United States, 94107
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Texas
Methodist Hospital Research Institute
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
InSightec
Additional Information:
Layout table for additonal information
Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT00981578    
Other Study ID Numbers: BM010
First Posted: September 22, 2009    Key Record Dates
Results First Posted: March 11, 2020
Last Update Posted: March 11, 2020
Last Verified: March 2020
Keywords provided by InSightec:
bone cancer
pain palliation
metastasis
breast cancer
lung cancer
prostate cancer
cancer related pain
tumors
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes